BioPhorum

BioPhorum Sustainability welcomes Moderna Inc to BioPhorum. We are delighted that you are joining this group, which together has the unique ability to build a strong coalition for change for an entire industry, and apply it to the greatest challenge of our generation.

Our mission is to act as a voice of the industry to enable delivery of the industry’s sustainability ambition quickly and effectively.
To lead innovative teams who have the capability and credibility to create consensus and ultimately drive real change that benefits people and planet. https://okt.to/S1XnOI

This paper is for all quality professionals who are working to understand the key areas where real-time release testing (RTRT) will impact the pharmaceutical quality system. It addresses the compliance challenges of RTRT and continued compliance with current good manufacturing standards.

Read more and download here - https://okt.to/Jl5KRr

Clarifying the misunderstandings associated with visual inspections, this paper talks about the key subjects of regulations, criticality and detectability, probability of detection, qualification vs. detection, and – importantly – why criticality and detectability of defects do not correlate.

Read more here - https://okt.to/zBaG8q

Introducing BioPhorum Council – taking back increased value to your organization

You can listen to the podcast here - https://okt.to/7vPDNO

Clare Simpson, Client Service Director, talks us through the concept of BioPhorum Council. What initiated the idea, and what opportunities will it provide? How will the Council feed into the work being advanced at the phorum and workstream level and who should be participating? Listen now to learn about this exciting launch, and then get in touch by contacting [email protected]

We assessed whether companies evaluated process parameters differently for clinical trial stages and commercialization. Read the full list of survey responses, included in a supporting information file alongside the article which discusses how worst-case conditions for a viral clearance step differ depending on its stage in a manufacturing process.

You can read more here - https://okt.to/kqjTwE

If you wish to receive our latest monthly newsletter you can sign up here - https://okt.to/esnRS1

Building and leveraging senior connections to help accelerate the industry vision further through BioPhorum membership is at the heart of the BioPhorum Council’s raison d’etre. Do you want to be involved?

You can view here - https://okt.to/ueHFT3

If you wish to receive our latest monthly newsletter you can sign up here - https://okt.to/6Kj8DA

While progress is being made, we must increase the pace of sustainability transformation across the value chain. This need has led to a demand from BioPhorum members for a harmonized industry approach across the entire biopharmaceutical sector to accelerate progress – the result is BioPhorum’s environmental sustainability roadmap.

You can download the roadmap here - https://okt.to/0dxQMS

With a key aim to ensure we have a common language and understanding across the industry, the Long-Range Planning Workstream is expanding its team to include those with knowledge of long-range planning processes. If you can share your knowledge and want to learn from other world-leading experts, then read on.

Read more here - https://okt.to/0RZv3f

Explaining the current state of integration models and the challenges faced by the industry, this paper is essential reading for business leaders in biomanufacturers and contract organizations, as well as digital leaders, integration, and IT solution providers providing operational and analytics systems.

Read more here - https://okt.to/WVxrko

There is still time to register for our upcoming webinar - Supporting particle investigations with risk-based decision-making

Wednesday, 30 November 2022 - 10:00 - 11:00 EST,
15-00 - 16:00 BST, 16:00 - 17:00 CET

The presence of visible particles in parenteral medicines is a perennial issue for the industry. How do companies manage particles when they are found, especially when atypical in nature? What can companies do to assess the risk of a particle, and how can a particle impact the future of a batch of a biopharmaceutical product?

Follow the link for more details and to register here - https://okt.to/FSgc4P

An informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
Read more here - https://okt.to/XeYjyJ

To provide an overview of the current and near-future bioprocess supply situation and trends, BioPhorum has collaborated with the biotechnology market strategy and research firm BioPlan Associates.

Read more here - https://okt.to/i15yce

Supply Chain to Patient inaugural meeting 15 – 16 November 2022
Register here - https://okt.to/WoqerO

The logistics of supplying biopharmaceuticals today differs from traditional blockbuster drugs. Volumes are smaller, shipment requirements differ, and capacity is at a premium leading to complexity and higher prices.

BioPhorum invites you to its launch workshop, which will address current capacity and resource challenges and set the future direction for the strategic challenges the industry will solve together through collaboration.

WEBINAR - Supporting particle investigations with risk-based decision-making

Wednesday, 30 November 2022 - 10:00 - 11:00 EST,
15-00 - 16:00 BST, 16:00 - 17:00 CET

The presence of visible particles in parenteral medicines is a perennial issue for the industry. How do companies manage particles when they are found, especially when atypical in nature? What can companies do to assess the risk of a particle, and how can a particle impact the future of a batch of a biopharmaceutical product?

Follow the link for more details and to register here - https://okt.to/E4T6YD

BioPhorum is proud to be part of CPHI Frankfurt, 1 - 3 November 2022 - CPhI Frankfurt | 2022 Conference Agenda

Andrea Johnston, Phorum Director, BioPhorum will present "Accelerating innovation and development of future biomanufacturing processes" at 15:35 on 2 November in track IV, Manufacturing Excellence.

Nicola Coles, Phorum Director, BioPhorum, and Caroline Calmels, Sustainability Market Manager, Saint Gobain Life Sciences - Bioprocess Solution will present "Developing a sustainability roadmap for the biopharmaceutical industry" at 12:15 on 3 November in the Product Innovation and Sustainability Theatre.

Our Business Development team will also be in attendance for anyone wanting to understand more about BioPhorum.

www.linkedin.com

Digital twins sound exciting, almost like science fiction. But what practical use could they be in biopharmaceutical manufacturing?

Talking with Kim Wilson, Dassault Systèmes, David Wallace draws on her expertize to show the opportunities and benefits of using virtual twins to optimize the supply chain, facility design, technology transfer, combination products, and sustainability.

https://okt.to/7wbXJk

An ECA, BioPhorum, and APIC Joint Conference
Raw materials, excipients, and APIs used for biological medicinal products

22 - 23 Nov, Dusseldorf, Germany

BioPhorum is delighted to partner on this joint conference. Janmeet Anant, Merck will present "Industry proposal for the use of QbD and ICH Q12 tools and principles to enable second sourcing of critical materials​", Amandine Calvet, Boeringer Ingelheim presents "BioPhorum approach to media fingerprinting testing of cell culture media" and Benjamin Jaquier, Takeda delivers the "BioPhorum raw materials strategic framework".

For the full program details and to register, visit the site here - Raw Materials, Excipients and APIs Used for Biological Medicinal Products - ECA Academy (gmp-compliance.org)

Establishing release specifications for plasmids, a critical starting material for cell and gene therapies: Seeking an industry consensus

Guest editorial: Discover how the industry is influencing efforts to advance a common approach to testing practices for plasmid release specifications.

Read more in the SelectScience® article by BioPhorum here -
https://okt.to/SQshrw

Cell & gene therapy: Release specifications for plasmids BioPhorum work aims to reach a consensus on test attributes and release requirements for plasmids and master cell banks

BioPhorum is proud to be part of CPHI Frankfurt, 1 - 3 November 2022.
https://okt.to/KJSXot

Andrea Johnston, Phorum Director, BioPhorum
Presentation - Accelerating innovation and development of future biomanufacturing processes.

Our Business Development team will also be in attendance for anyone wanting to understand more about BioPhorum. Get in touch here - [email protected]

In this podcast, BioPhorum talks to Brian and Brent about the future of collaboration across biopharmaceutical supply chains.
How can the biopharmaceutical industry move away from highly manual information exchange?

Listen to the podcast here - https://okt.to/7cet6N

How can your company benefit from collaboration with BioPhorum?

If you would like to learn more about this exciting collaboration opportunity, email [email protected]

We are hiring!
https://okt.to/suIZVP

Our sales team is rapidly expanding and we are now looking for a Business Development Manager with solution-based sales experience and knowledge of the biotechnology industry supply chain.

Looking for a change within the pharmaceutical and biotechnology industry? Are you ambitious, do you strive to meet sales targets, and can you make good connections with both your colleagues and customers? Then this might be for you.

We are looking for an experienced sales-driven professional to drive growth for the business. You’ll have the opportunity to connect and collaborate with the whole value chain, from pharmaceutical and biotechnology companies to logistic companies, warehouses, and suppliers

Interested? For more information click here - https://okt.to/bd5w4Q

BioPhorum is pleased to share for the first time the full design documentation from a Proof-of-Concept which has performed beyond expectations, marking a step change in the biomanufacturing industry’s approach to buffer stock preparation.

BioPhorum’s Buffer Prep Workstream collaborated with the National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL) to design and build a Buffer Stock Blending (BSB) System, demonstrating the performance of its recipe-based approach to support on-demand automated buffer delivery for biopharmaceutical processes through precise buffer stock solution blending using mass flow control.

Tim Hawkins, BioPhorum CEO explains “Having recognized that buffer blending was becoming a bottleneck for modern biomanufacturing facilities, the BioPhorum team rapidly established a concept design that would be low cost, flexible, and reduce facility footprint. BioPhorum was delighted to partner with NIIMBL, which enabled funding to build and test in its facility. By freely sharing this data we intend to accelerate the industry's adoption of this transformational technology and look forward to seeing biomanufacturers across the world enjoy the substantial benefits that will flow as a result”.

Members from Automation involved in the collaboration, Doan Chau and Ryan Campbell, state ‘The release of the Buffer Stock Blending System PDA paper, addendum, and open-source documentation set will be valuable for biomanufacturers in adopting this new technology. This open sharing of the design will provide the design documents, drawings, application code, data sets, and test results to lower the barrier to adoption, giving the industry the confidence to move forward from traditional manual ways of working in buffer prep operations. As this technology is adopted and utilized in manufacturing, continual feedback will be critical in progressing the optimization of the system and the technology.’

Read more here - https://okt.to/uidIvK

BioPhorum MedTech human factors survey – what do you think?
We'd like to hear from you.

Click here to respond
👉🏻 https://bit.ly/3PhbvQU

BioPhorum MedTech has initiated a working group to explore the experiences and issues within human factors (HF) studies, predominately related to biomanufacturers of combination products.

Running from July 2022, the Phorum’s human factors working group has issued a survey to collect data on the current understanding of a range of topics affecting HF teams in the industry. The survey will take around 30 minutes of your time.

The on-time in-full (OTIF) metric is a good indicator of the general health of the supply chain. It measures the extent to which shipments are delivered to their destination according to the quantity and schedule specified on the order.

Ream more..https://bit.ly/3OWMaeo

Improving the understanding and clarity around ‘on-time in-full' Know more about modern robotics, environmental monitoring solutions and more! Click to read our post: Improving the understanding and clarity around ‘on-time in-full'!

Current regulatory guidance is limited in defining expectations for the release of plasmids as a starting material. BioPhorum collaborated to propose a platform framework to stimulate a broader industry discussion..
Read more

Building on industry feedback to standardize plasmid release specifications Know more about modern robotics, environmental monitoring solutions and more! Click to read our post: Building on industry feedback to standardize plasmid release specifications!

A fantastic opportunity to part of

We’re looking to grow our team of professional Facilitators who can design and deliver a portfolio of workstreams that bring about lasting impact to the global BioPharma industry.

These roles give you the chance to work with and facilitate conversations on innovative industry areas, all while being part of a high-growth, ambitious business. We’re particularly interested in people with backgrounds in project management, facilitation, consulting or change management and who’ve worked in areas such as Drug Substance, IT, Clinical Supplies and Regulation.

👉🏻 For more information and to apply click here https://bit.ly/3yXmMiz 👈🏻

Another fantastic opportunity to be part of

We’re growing our team of Account Managers who work with and act as a strategic advisor to some of the most senior stakeholders from across the industry and helping to create future visions that focus energy on the topics that matter most .

These roles give you the chance to build ground-breaking programs and converse on innovate industry ideas, all while being part of a high-growth, ambitious business.

We’re particularly interested in people with a deep knowledge of the biopharmaceutical sector in areas such as biologics, drug substance, and regulation and who can demonstrate experience of building successful client relationships, adding value to clients and driving revenue in a similar high-growth biopharmaceutical business.

👉🏻 For more information and to apply click here https://bit.ly/3IUlXeO 👈🏻

You can save a significant amount of time when searching for information about high-risk host cell protein (HCP) impurities, by using BioPhorum's database: https://bit.ly/3GBIgVL

BioPhorum is delighted to hear feedback on the value provided by its host cell proteins searchable database at last week's BEBPA conference. It has been cited multiple times in industry papers and presentations too!

Follow this link to the database: https://bit.ly/3GBIgVL